Seattle Urology Research Center, Seattle, WA, USA.
Clinical Research Consulting, Milford, CT, USA.
Int J Clin Pract. 2021 May;75(5):e13937. doi: 10.1111/ijcp.13937. Epub 2021 Jan 22.
Quality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β -adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.
Patients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.
Of the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB-q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end-points at week 12 (P < .05 each) and were classified as responders (P < .05 each).
In the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.
ClinicalTrials.gov identifier number NCT03492281.
膀胱过度活动症 (OAB) 的症状会显著影响生活质量 (QOL)。维贝格隆是一种高选择性 β-肾上腺素能受体激动剂，在随机、双盲、安慰剂对照和活性对照 3 期 EMPOWUR 试验中显示出对 OAB 症状的治疗效果。在此，我们报告来自 EMPOWUR 试验的患者报告的 QOL 结果。
患者随机分为 5:5:4 组，分别接受维贝格隆 75mg、安慰剂或托特罗定 4mg 缓释片治疗，疗程为 12 周。患者在基线和第 12 周时完成 OAB 问卷 (OAB-q)，在基线和第 4、8、12 周时完成患者总体印象 (PGI) 量表，用于评估严重程度、控制程度、频率和漏尿情况。从基线到第 12 周的变化和应答率（OAB-q：患者获得≥10 分的改善；PGI：患者报告最佳反应）进行评估。将维贝格隆与安慰剂进行比较，且未对维贝格隆与托特罗定进行比较。
在 1518 名随机患者中，1463 名（安慰剂，n=520；维贝格隆，n=526；托特罗定，n=417）具有可评估疗效的资料，纳入分析。治疗组的基线 OAB-q 和 PGI 评分相当。在第 12 周时，与接受安慰剂的患者相比，接受维贝格隆治疗的患者在 OAB-q 亚量表的应对、担忧、睡眠、健康相关 QOL 总分和症状困扰方面有更大的改善（P<0.01）；与接受安慰剂的患者相比，接受维贝格隆治疗的患者在 OAB-q 应对（P<0.05）和症状困扰评分（P<0.0001）方面的应答者比例更高。与安慰剂相比，接受维贝格隆治疗的患者在第 12 周时在所有 PGI 终点上获得最佳反应的比例更高（P<0.05），且被归类为应答者（P<0.05）。
在为期 12 周的 EMPOWUR 试验中，与安慰剂相比，维贝格隆治疗与 OAB-q 和 PGI 评分的显著和有临床意义的改善相关，与 OAB 症状的改善一致。
ClinicalTrials.gov 标识符 NCT03492281。
